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Risk Management in Sterile Manufacturing
23-24 September 2008
Heidelberg, Germany
Please click here to view the program of this conference or course
To book for this program, just click on the option:
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At this conference we offer a Conference Exhibition.
Please click here in order to view the registration form (PDF) for exhibitors.
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Learning Goals
Why you should attend this course:
- You get to know the methods of risk analysis and learn how to apply them to the specific questions of sterile manufacturing
- You can distinguish between critical and uncritical risks and accordingly define measures for controlling these risks
- In workshops, you analyse sterile processes, assess possible risks and suggest suitable countermeasures
Background
The manufacture of sterile medicinal products is a risk-prone process. Whereas the product safety of terminally sterilised products can usually be ensured by validating the sterilisation process, aseptic manufacture makes great demands on process safety. As early as 2001, the FDA had defined the „Risk-Based Approach“ for future inspections; involving high risk in the sense of the authority‘s definition and therefore being automatically in the focus of inspections is „aseptic processing“.
Even in advance, one has to study the question whether each process step poses a contamination risk, and if so, which one. Good risk management consists in identifying and assessing risks in time and taking measures in the production process in order to control or - if possible - eliminate these risks.
Everyday routine confronts us with a multitude of potential risks. Which of them are critical, which ones rather uncritical? How can risk assessment be done and which rationales play a role in this decision?
The speakers provide you with practice-oriented approaches to assessing, controlling and reducing risks in -sterile processes- and to get safely through inspections. |
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